October-December 2018 Regulatory Update

These Regulatory Updates are brought to you by Michael Best & Friedrich.  This Regulatory Update includes information from October 2018 through December 2018. Please contact Seth Mailhot, Leah Ziemba, or Emily Lyons for additional information on regulatory issues that may impact upon your business.

The October–December 2018 Regulatory Update includes several MUST READ updates:

Click on the >>Read More link for the complete regulatory update.

FDA AND USDA UPDATES
>>Read More

• USDA Releases National Bioengineered Food Disclosure Standard for Labeling of Genetically Modified Foods (MUST READ)
• FDA Issues Two Guidance Documents for Nutrition Fact Labeling (MUST READ)
• FDA Considers Recognizing Sesame as Allergen
• FDA Announces Qualified Health Claim for Consuming Oils with High Levels of Oleic Acid to Reduce Coronary Heart Disease Risk
• USDA-FSIS Announces Uniform Compliance Dates for Food Labeling Regulations

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES
>>Read More

• Mandatory Recall Guidance Issued (MUST READ)
• FDA Issue Two Guidance Documents on FSMA Requirements for Produce Growers and Processors (MUST READ)
• Training Available to Meet Requirements of Intentional Adulteration Rule (MUST READ)

OTHER DEVELOPMENTS OF INTEREST
>>Read More

• FDA Extends Comment Period on Use of Dairy Names on Plant-Based Foods
• USDA-FSIS Issues Directive on Safe and Suitable Ingredients used in the Production of Meat, Poultry, and Egg Products
• FDA Launches Online Training on Menu Labeling
• USDA and FDA to Jointly Regulate Cell-Cultured Food Products
• FDA Reminds Food Companies to Obtain Third-Party Certification to Export to China, Issues Updated Guidance
  
  
  
  

FDA AND USDA UPDATES

USDA Releases National Bioengineered Food Disclosure Standard for Labeling of Genetically Modified Foods (MUST READ)

On Thursday, December 20, 2018, the U.S. Department of Agriculture (USDA) released a pre-publication copy of the final rule establishing the national bioengineered (BE) food disclosure standard.  This rule is the first time that a uniform, federal mandatory standard for the disclosure of genetically modified (GM) foods will be implemented.  Food companies will have the option to disclose the BE content of their foods via text, symbol, electronic or digital link, or text message.

Learn more about this final rule and what it means for your business in Michael Best’s Client Alert.

FDA Issues Two Guidance Documents for Nutrition Fact Labeling (MUST READ)

FDA recently issues two guidance documents to assist food manufacturers in complying with the new changes to the nutrition labeling requirements.  The first document is a final guidance that addresses the compliance date, added sugars definition, and quantitative declarations of vitamins and minerals.  The second document is a draft guidance that focuses on the serving size, Reference Amounts Customarily Consumed (RACCs), and determining the appropriate Nutrition Facts Panel (NFP) format, including dual-column labeling.

Reminder: Food manufacturers with $10 million or more in annual food sale have until January 1, 2020 to convert labels to meet the new labeling requirements, small manufacturers with less than $10 million in annual food sales have until January 1, 2021.

FDA Considers Recognizing Sesame as Allergen

FDA recently issued a request for information seeking data and other information on the prevalence and severity of sesame allergies in the U.S. and the prevalence of sesame-containing foods in the marketplace that are not currently required to disclose the presence of sesame. FDA will use this data to inform potential rulemaking that could require food labels to disclose the presence of sesame as an allergen in order to protect and promote public health. >>Learn More

FDA Announces Qualified Health Claim for Consuming Oils with High Levels of Oleic Acid to Reduce Coronary Heart Disease Risk

FDA announced it would exercise enforcement discretion over two qualified health claims characterizing the relationship between the reduced risk of coronary heart disease and the consumption of oleic acid in edible oils in foods containing at least 70% of oleic acid per serving when consumed in place of saturated fats.  To be eligible to bear the high oleic acid edible oils and CHD qualified health claim, the high oleic acid-containing oil must contain 5 grams of oleic acid per reference amount customarily consumed (RACC). >>Learn More

USDA-FSIS Announces Uniform Compliance Dates for Food Labeling Regulations

USDA- Food Safety Inspection Service (USDA-FSIS) has announced that January 1, 2022 as the uniform compliance date for new meat and poultry labeling regulations that will be issued between January 1, 2019 and December 31, 2020.  USDA-FSIS announced uniform compliance dates for labeling regulations to minimize the economic impact of label changes. >>Read the USDA-FSIS Announcement

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

Mandatory Recall Guidance Issued (MUST READ)

In early November, FDA released a Question and Answer guidance document regarding situations when FDA may consider using its mandatory recall authority.  The Guidance outlines that FDA will give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory retail and discusses details about situations when FDA deems a food a serious health risk necessitating the need for a mandatory recall.

In a statement accompanying the Guidance, FDA Commissioner Scott Gottlieb, M.D. explained that the Guidance provides additional clarity and enables FDA to make more robust use of the mandatory recall authority. >>Read Dr. Gottlieb’s Full Statement

FDA Issue Two Guidance Documents on FSMA Requirements for Produce Growers and Processors (MUST READ)

FDA has issued two draft guidance documents intended to assist produce growers and processors in complying with certain FSMA regulations.  The first document is for farms covered by the Produce Safety Rule and outlines how farms can determine if they are eligible for exemptions from some or all of the rule’s requirements and also provides FDA’s recommendations for satisfying certain requirements rule.  The second document is for facilities subject to FDA’s Preventive Controls for Human Food rule  that manufacture, process, pack, or hold fresh-cut produce. The deadline for comments on both guidance documents is April 22, 2019

Training Available to Meet Requirements of Intentional Adulteration Rule (MUST READ)

The Food Safety Preventive Controls Alliance recently announced the release of the online course "Conducting Vulnerability Assessments Using Key Activity Types.”  This course satisfies the training requirement in the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule to conduct a vulnerability assessment if using the Key Activity Types method.  Facilities not exempt from the rule must comply with this FSMA regulation by July 26, 2019, while small facilities, a business employing fewer than 500 employees, have until July 26, 2021 to comply.

OTHER DEVELOPMENTS OF INTEREST

FDA Extends Comment Period on Use of Dairy Names on Plant-Based Foods

FDA has extended the comment period on the use of dairy terms such as "milk,” "yogurt,” and "cheese” on plant-based foods and beverages until January 28, 2019. >>Comment Here

USDA-FSIS Issues Directive on Safe and Suitable Ingredients used in the Production of Meat, Poultry, and Egg Products

In early December, USDA-FSIS issued an updated list of substances that may be used in the production of meat, poultry, and egg products. >>Learn More

FDA Launches Online Training on Menu Labeling

Recently, FDA released an online education module to help industry, regulatory, and consumers understand the new menu labeling regulations.  This online training describes what types of establishments and types of foods are covered by the menu labeling regulations and how to comply with the regulations. FDA also published two fact sheets for industry on menu labeling and declaring calories.

USDA and FDA to Jointly Regulate Cell-Cultured Food Products

Following a public meeting, FDA and USDA announced that both agencies will jointly oversee the production of cell-cultured food products derived from livestock and poultry.  FDA will oversee cell collation, cell banks, and cell growth and differentiation, while USDA oversees oversee the production and labeling of food products derived from the cells of livestock and poultry. 

FDA Reminds Food Companies to Obtain Third-Party Certification to Export to China, Issues Updated Guidance

China requires U.S. dairy, seafood, and infant formula exporters to obtain a third-party certification to verify compliance with Chinese laws and regulations and to update its information on the Food and Drug Administration’s list of eligible exporters to China. Dairy, sea food, and infant formula companies shipping products to China must take these steps by June 15, 2019, to remain eligible exporters. FDA also released updated guidance on these requirements that clarifies how to apply electronically and update list data, and lists products that are exempt from the certification requirements.

*Federal agencies accept public comments from interested stakeholders even if a comment period has closed.